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Lipid-Lowering Agent

Bempedoic acid + Ezetimibe FDC for Diabetes

Phase 2
Waitlist Available
Research Sponsored by Esperion Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 16 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C

Eligible Conditions
  • Diabetes
  • High cholesterol
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)
Secondary study objectives
Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)
Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12
Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12
+8 more
Other study objectives
Therapeutic procedure
Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)
Percent Change From Baseline to Week 12 in Fasting Plasma Glucose
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Bempedoic acid + Ezetimibe FDCExperimental Treatment2 Interventions
Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule
Group II: Ezetimibe 10 mgActive Control2 Interventions
Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet
Group III: PlaceboPlacebo Group2 Interventions
Placebo Oral Tablet, Placebo oral capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ezetimibe
FDA approved
Placebo oral capsule
2010
Completed Phase 4
~2380

Find a Location

Who is running the clinical trial?

Esperion Therapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
21,676 Total Patients Enrolled
Ron Haberman, MDStudy DirectorEsperion Therapeutics, Inc.
7 Previous Clinical Trials
4,127 Total Patients Enrolled
~32 spots leftby Nov 2025
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